PEDS-C: Pegylated Interferon +/- Ribavirin for Children With Hepatitis C

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ClinicalTrials.gov Identifier: NCT00100659

Recruitment Status
:
Completed

First Posted
: January 5, 2005

Results First Posted
: July 1, 2013

Last Update Posted
: July 19, 2013

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator:

Roche Pharma AG

Information provided by (Responsible Party):

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

The purpose of this study is to determine the safety and efficacy of peginterferon alfa-2a (PEG-2a) in combination with ribavirin (RV) and PEG-2a alone for the treatment of chronic hepatitis C virus (CHC) infection in children.

The purpose of this study is also to determine whether PEG-2a in combination with RV or PEG-2a alone will result in a longer response rate in children with CHC.

Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).

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Ages Eligible for Study:

5 Years to 18 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female patients who are 5-18 years of age at enrollment (not yet reached 18th birthday at screening).

Chronic liver disease, as indicated by inflammation and/or fibrosis, consistent with chronic hepatitis C infection on a liver biopsy obtained within the past 24 months, as assessed by a qualified pathologist, not consistent with other known liver disease and not normal.

Major depression according to the American Psychiatric Association, or a history of severe psychiatric disorder, such as major psychoses, suicidal ideation and/or suicide attempt

History or other evidence of chronic pulmonary or cardiac disease associated with functional limitation

History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease are excluded

Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is >20% within 2 years.

Hemoglobinopathy

Hemophilia

Severe retinopathy

History of other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study

Sexually active females of child-bearing potential (defined as age 10 years and older) and sexually active men who are not practicing two forms of effective contraception during treatment and during the 6 months after treatment has been concluded

Females who have a positive serum pregnancy test within 7 days of initiation of treatment or who are breast-feeding

Males whose female partners are pregnant

Active substance abuse

A sibling and/or any other child living in the same household or sharing the same primary caregiver enrolled in the study.